Health Canada Summary Safety Review: Colistin

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Health Canada has asked that CPSA notify registered members of a summary safety review (SSR) regarding colistin (colistimethate sodium) and the potential risk of pseudo-Bartter syndrome.

Product: Colistin (colistimethate sodium)-containing products

Potential safety issue: Pseudo-Bartter syndrome, a disorder involving acid-base and electrolyte imbalances

Key messages:

• Health Canada’s safety review found a link between the use of colistin (colistimethate sodium) and the risk of pseudo-Bartter syndrome.
• Health Canada reviewed the potential risk of pseudo-Bartter syndrome with the use of colistin (colistimethate sodium), a prescription antibiotic drug authorized for sale in Canada to treat acute or chronic infections, such as pneumonia, bloodstream infections and meningitis (infection of the protective membranes covering the brain and spinal cord). The safety review was triggered by published case reports in the scientific literature.
• Health Canada is working with the manufacturers to update the product safety information in the Canadian product monograph (CPM) for colistin (colistimethate sodium)-containing products with a warning about reported cases of pseudo-Bartter syndrome.

For more information, please visit the Drug and Health Product Portal.